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Energetic Dissection of Mab-Specific Reversible Self-Association Reveals Unique Thermodynamic Signatures

Autor: David L. Bain, Mandi M. Hopkins, Arun Parupudi, Jared S. Bee

Publikováno v: Pharmaceutical Research. 38:243-255

Reversible self-association (RSA) remains a challenge in the development of therapeutic monoclonal antibodies (mAbs). We recently analyzed the energetics of RSA for five IgG mAbs (designated as A-E) under matched conditions and using orthogonal metho

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::94c82c59f98abd5913b9b5c75f259b12
https://doi.org/10.1007/s11095-021-02987-0

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Monoclonal Antibody Dimers Induced by Low pH, Heat, or Light Exposure Are Not Immunogenic Upon Subcutaneous Administration in a Mouse Model

Autor: Bram Slütter, Jared S. Bee, Samuel A. Korman, Wim Jiskoot, Mark A. Schenerman, Yuling Wu, Grzegorz Kijanka

Publikováno v: Journal of Pharmaceutical Sciences
Journal of Pharmaceutical Sciences, 109(1), 730-738

The presence of protein aggregates is commonly believed to be an important risk factor for immunogenicity of therapeutic proteins. Among all types of aggregates, dimers are relatively abundant in most commercialized monoclonal antibody (mAb) products

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6f7fc929162e616ebfb10a734232c12b
https://doi.org/10.1016/j.xphs.2019.04.021

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Mechanistic Studies and Formulation Mitigations of Adeno-associated Virus Capsid Rupture During Freezing and Thawing: Mechanisms of Freeze/Thaw Induced AAV Rupture

Autor: Jared S, Bee, Yu, Zhang, Sheyla, Finkner, Kristin, O'Berry, Akanksha, Kaushal, Megan Kuhn, Phillippi, Roberto A, DePaz, Keith, Webber, Tristan, Marshall

Publikováno v: Journal of pharmaceutical sciences. 111(7)

Gene therapies delivered using adeno-associated virus (AAV) vectors are showing promise for many diseases. Frozen AAV drug products are exposed to freeze-thaw (F/T) cycles during manufacturing, storage, and distribution. In this work we studied the m

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::8b88214ceab46d0dbf2b658c5db0f947
https://pubmed.ncbi.nlm.nih.gov/35351496

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Impact of Time Out of Intended Storage and Freeze-thaw Rates on the Stability of Adeno-associated Virus 8 and 9

Autor: Jared S. Bee, Yu (Zoe) Zhang, Megan Kuhn Phillippi, Sheyla Finkner, Tesfu Mezghebe, Keith Webber, Win Den Cheung, Tristan Marshall

Publikováno v: Journal of pharmaceutical sciences. 111(5)

There are an increasing number of clinical studies evaluating different adeno-associated virus (AAV) serotypes as vectors for gene therapy. Long-term frozen storage can maximize the stability of AAV. Freeze-thaw (F/T) cycles and exposures to room tem

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::dea2d47e2decad6afd915def76befa9c
https://pubmed.ncbi.nlm.nih.gov/34999092

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Investigation of cathepsin D–mAb interactions using a combined experimental and computational tool set

Autor: Swarnim Ranjan, David Robbins, Wai Keen Chung, Limin Zhang, Steven M. Cramer, Romina V. Hofele, Jared S. Bee, Jenny Heidbrink Thompson

Publikováno v: Biotechnology and Bioengineering. 116:1684-1697

Cathepsin D has been identified as a challenge to remove in downstream bioprocessing of monoclonal antibodies (mAbs) due to interactions with some mAbs. This study focused on investigating the mechanisms of interaction between cathepsin D and two ind

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::51a06e55ee8d4fad8369b06b3fe3b607
https://doi.org/10.1002/bit.26968

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Development of a stable lyophilized adeno-associated virus gene therapy formulation

Autor: Tristan Marshall, Roberto A DePaz, Yu Zoe Zhang, Jared S. Bee

Publikováno v: International journal of pharmaceutics. 606

Adeno-associated viruses (AAV) are among the most actively investigated vectors for gene therapy. Supply of early clinical studies with frozen drug product (DP) can accelerate timelines and minimize degradation risks. In the long-term, logistical cha

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6c087dd881b8ca9b258583d6755ac2fd
https://pubmed.ncbi.nlm.nih.gov/34298099

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Quantitation of Trace Levels of DNA Released from Disrupted Adeno-Associated Virus Gene Therapy Vectors

Autor: Yu Zoe Zhang, Jared S. Bee, Megan Kuhn Phillippi, Kristin B. O'berry, Roberto A DePaz, Akanksha Kaushal, Tristan Marshall

Publikováno v: Journal of pharmaceutical sciences. 110(9)

Adeno-associated virus (AAV) vectors for gene therapy have potential to provide a durable treatment response for a number of diseases with unmet need. DNA is released from AAV capsids at high temperatures. Less is known about DNA release that may occ

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::81e24c8407bf83abf24319290077bc60
https://pubmed.ncbi.nlm.nih.gov/34107283

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